Reducing the Life Cycle Cost of Validation:
Part 3 – Equipmnet Selection, Processing, and Maintenance
Selecting the most appropriate material and having a well-planned mold design, as discussed in Part One and Part Two of this series, are essential pieces of establishing the long-term success and longevity of your medical device validation. However, without the right equipment, you cannot determine the dependability and repeatability needed to ensure a high level of quality and production uptime required for the lifetime of your product’s production needs. In the final installment, we will discuss how to select your equipment correctly, ensure it can consistently function as needed, and what you need to do to maintain its performance day after day.
Equipment Selection: Performance Over Pricing
When selecting an injection molding machine, robotics equipment, and/or temperature control units (TCUs), also known as mold conditioners, look for those that are proven to be repeatable and reliable. For example, if you need your injection molding machine to stop with an accuracy of .0005” injection stroke, you must make sure it can perform as required time and time again. It must also be able to consistently hit whatever pressure is needed at the pack and at hold. A machine with hydraulics will sometimes overshoot or undershoot, whereas an electric machine will run the necessary pressure and stay there with little fluctuation. With TCUs, ensure the equipment has a strong enough pump to deliver enough gallons per minute (GPM) of cooling media to your tool so you can maintain a constant cooling rate during your production runs. This is something you will need to confirm during the installation qualification testing and process setting activities.